Veterinary Medicines

FIXR Coli

Authorised
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), Inactivated
  • Escherichia coli, serotype K85:987P (fimbrial adhesin F6), Inactivated
  • Escherichia coli, serotype O147:K88 (fimbrial adhesin F4ab), Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), Inactivated
  • Escherichia coli, serotype O149:K88 (fimbrial adhesin F4ac), Inactivated
Download as PDF

Product identification

Medicine name:
FIXR Coli
FIXR Coli, emulsie voor injectie voor varkens
Active substance:
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), Inactivated
  • Escherichia coli, serotype K85:987P (fimbrial adhesin F6), Inactivated
  • Escherichia coli, serotype O147:K88 (fimbrial adhesin F4ab), Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), Inactivated
  • Escherichia coli, serotype O149:K88 (fimbrial adhesin F4ac), Inactivated
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype K85:987P (fimbrial adhesin F6), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O147:K88 (fimbrial adhesin F4ab), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O149:K88 (fimbrial adhesin F4ac), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • 1 × 50 ml glass vial airtight sealed with rubber pierceable stoppers and fitted with aluminium caps, inserted into cardboard boxes.
  • 1 × 20 ml glass vial airtight sealed with rubber pierceable stoppers and fitted with aluminium caps, inserted into cardboard boxes.
  • 1 × 100 ml plastic vial of 120 ml airtight sealed with rubber pierceable stoppers and fitted with aluminium caps, inserted into cardboard boxes.
  • 1 × 100 ml glass vial airtight sealed with rubber pierceable stoppers and fitted with aluminium caps, inserted into cardboard boxes.
  • 1 × 10 ml, glass vial airtight sealed with rubber pierceable stoppers and fitted with aluminium caps, inserted into cardboard boxes.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Similar biological application (Article 13(4) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Kernfarm B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 125015
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0332/001
Concerned member states:
  • Belgium

Documents

Combined File of all Documents

English (PDF)
Published on: 24/04/2025
Download
Dutch (PDF)
Published on: 24/04/2025
Download